The Medical Director, Global Risk Management & Safety Surveillance (GRMSS), reporting into the Head of GRMSS, will be responsible for developing and ensuring execution of all patient safety risk management activities for molecular entities under clinical development as well for marketed products. This will include pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions. The position will require strong oversight for patient safety issues that arise at both the individual case safety report (ICSR) and aggregate levels (within the company and in collaboration with co-development partners); strong decision-making skills on all issues involving safety assessment and surveillance; responsibility for compliant, timely, and complete regulatory authority engagement (with particular emphasis on benefit-risk assessments and risk identification/characterization and mitigation/management); and effective communication of safety information to internal and external stakeholders.
location: Wilmington, Delaware
job type: Permanent
salary: $250,000 - 275,000 per year
work hours: 9 to 5
- Lead Safety Management Team and direct all safety risk management activities for assigned products.
- Ensure local and global risk management plan preparation and execution throughout a medicinal product's lifecycle.
- Formulate clinical trial and postmarketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies.
- Perform drug safety signal detection activities for portfolio of investigational and marketed products; develop medically reasonable evaluations of safety signals; and make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals.
- Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
- Medically review ICSRs and provide follow-up guidance to Case Operations team to ensure consistent high-quality reports.
- Review literature regarding products, as well as relevant products from collaboration partners, to identify new and important information that potentially impact human safety; conduct reviews both independently within and in conjunction with external collaboration partners.
- Drive preparation of IND Annual Reports and/or DSURs for clinical trial programs, and PADERs and/or PSURs for marketed products.
- Perform Health Hazard Evaluations.
- Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
- Drive the safety strategy for Reference Safety Information for products, including Investigator Brochures and new or updated labeling (USPI or CDS) for marketed products in the context of multidisciplinary groups within or joint committees between external partners.
- Participate in internal safety process improvements and updates, including new means of effective presentation of early phase clinical study status reports with regard to safety findings.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS.
- Review medical and safety content included in standard response letters prepared by Medical Affairs, as necessary, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
- Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (eg, regulators and commercial collaborators) stakeholders.
- Serve as the GRMSS medical representative for joint clinical development programs with external partners as designated by the Head, GRMSS.
- M.D. or US/international equivalent.
- 5 years total pharmaceutical/biotechnology industry experience, of which more than 2 years will have been in a pharmacovigilance or risk management role.
- In-depth knowledge of US/EU risk management/GVP landscape.
- First-hand experience interacting with regulators with risk management issues.
- Experience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, and Clinical Overviews).
- M.P.H. or relevant epidemiology experience in industry or academia preferred.
- Board certification in internal medicine or pediatrics (primary care) or hematology/oncology (specialty) preferred.
- Experience in pharmaceutical industry activities outside the United States preferred.
- Experience in clinical trial development and execution preferred.
- Training or experience in oncology or inflammatory diseases, or clinical safety support of oncology, immunomodulatory, or other related products preferred.
skills: Pharmacovigilance, Pharmacoepidemiology, ARISg, Argus, Drug Safety, DSUR (Development Safety Update Report), Pharmacogenetics, Pharmacogenomics, RMP (Risk Management Plan), SAE (Serious Adverse Event), SD (Signal Detection), AD (Adverse Events), ICSR (Individual Case Study Report), MedDRA, PBRER (periodic Benefit Risk Evaluation Report), PSUR (Periodic Safety Update Report)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.